But Addyi is OK'd only for premenopausal women and carries risks

The U.S. Food and Drug Administration (FDA) has approved for premenopausal women the first-ever drug for low female libido.

The new drug, Addyi (flibanserin; dubbed “female Viagra” by some), was developed by Sprout Pharmaceuticals for a condition known as acquired, generalized Hypoactive Sexual Desire Disorder (HSDD), which affects up to 1 in 10 women in the United States, according to a company press release.

“It has been a remarkable journey to get to this breakthrough moment,” said Sprout Pharmaceuticals Chief Executive Officer Cindy Whitehead, in a press statement. “Today we celebrate what this approval means for all women who have long awaited a medical treatment option for this life-impacting condition.”

Critics of the new drug say it is ineffective and unsafe, however. Side effects include a severe drop in blood pressure and fainting. Women are advised to abstain from alcohol while taking Addyi. (The drug contains a boxed warning to that effect.)

It may improve sexual desire, but it’s not like a home run drug — it’s more like a first base drug.

— Dr. Wulf Utian, North Amer. Menopause Society

Other potential side effects include sleepiness, fatigue, nausea, insomnia and dry mouth.

Does It Work?

The drug is not indicated for post-menopausal women, though doctors can prescribe it off-label.

Sprout said that having already studied Addyi in post-menopausal women, the company plans to pursue FDA approval for that group in the future. “The safety and efficacy of Addyi has not been established in men,” it added in a statement.

Dr. Wulf Utian, founder and medical director of The North American Menopause Society (NAMS), a nonprofit scientific organization devoted to women at midlife and beyond, said he has had misgivings about the drug, which he described as “marginally effective.”

Said Utian: “It may improve sexual desire, but it’s not like a home run drug — it’s more like a first base drug.” In clinical trials, use of the drug increased women’s number of “satisfying sexual events” by one-half to one additional event per month over a placebo.

“Is it effective enough to justify its having been approved?” Utian asked. “To me that‘s a crucial question. My feeling is probably not.”

The Fight For Approval

A campaign called Even the Score pushed for the approval of flibanserin, accusing the FDA of unfairly limiting drugs for women’s sexual problems while approving treatments for men. A number of women’s groups, including the National Organization for Women, signed on. The effort was funded in part by Sprout.

The FDA strongly rejected claims of gender bias, it said in a June statement. “We are committed to working with companies to develop safe and effective treatments for female sexual dysfunction, as we do for all diseases with unmet medical needs.”

The FDA’s Center for Drug Evaluation and Research (CDER) Director, Dr. Janet Woodcock, said Aug. 18,:“Today’s approval provides women distressed by their low sexual desire with an approved treatment option. The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

However, she said, “Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies.”

Possible Serious Side Effects

Utian said the safety questions are worrisome.

“The concerns are, this is not like Viagra, where you just take it when you need it,” he said. Addyi is taken every day, at bedtime. The possible drop in a woman’s blood pressure and fainting “could affect her at any moment,” such as when she is driving, Utian said. That’s especially true if she drinks alcohol.

Utian added he hoped research would continue into drugs for women’s sexual disorders.

Sprout said a one-month supply of the drug is estimated to come with a $30 to $75 co-pay per month for patients. To further reduce the out-of-pocket cost, the company said it is also planning to offer a “point of purchase co-pay assistance program” in early sales.